Key Specialized Monitoring of Clinical Safety of Pudilan Xiaoyan Oral Liquid in the Real World

NCT ID: NCT04031651

Last Updated: 2019-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-17

Study Completion Date

2021-12-31

Brief Summary

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To obtain the characteristics of adverse reactions/incidents, analyze the influencing factors and calculate the incidence of adverse reactions/incidents monitored by Pudilan Xiaoyan Oral Liquid in key specialties in the real world, so as to provide a basis for clinical safe and rational drug use.

Detailed Description

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Conditions

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Respiratory Infectious Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pudilan Xiaoyan Oral Liquid

In the respiratory and emergency departments of the hospitals under surveillance, the medication of Pudilan Xiaoyan Oral Liquid is observed for those aged 18-80 years who strictly follow the prescription of the instructions.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* (1)Upper respiratory tract infection patients using Pudilan antiphlogistic oral liquid ;
* (2)Aged between 18 and 80.

Exclusion Criteria

* Lactating women, pregnant women, pregnant planners, psychiatric patients, etc.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Yanming Xie

Deputy Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanming Xie, BA

Role: PRINCIPAL_INVESTIGATOR

Institute of Basic Research in Clinical Medicine, China Academy of Chinese

Central Contacts

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Yanming Xie, BA

Role: CONTACT

86-13911112416

Qing Miao, doctor

Role: CONTACT

86-13910812309

References

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Wang M, Wang L, Liu F, Chen R, Wang Z, Cui X, Li Y, Xie Y. Clinical Safety of Pudilan Xiaoyan Oral Liquid for the Treatment of Upper Respiratory Tract Infection in the Real World: Protocol for a Prospective, Observational, Registry Study. JMIR Res Protoc. 2025 Mar 21;14:e65789. doi: 10.2196/65789.

Reference Type DERIVED
PMID: 40117581 (View on PubMed)

Other Identifiers

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PUDILAN

Identifier Type: -

Identifier Source: org_study_id

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